BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30327 12CC 100 UNIT HEP SYR {CAN} 2.5CC

    MDR report key: 1791026 · Received July 20, 2010

    Report

    Report Number
    3002859087-2010-00138
    Event Type
    Malfunction
    Date Received
    July 20, 2010
    Date of Event
    January 1, 2007
    Report Date
    July 14, 2010
    Manufacturer
    COVIDIEN
    Product Code
    NZW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2010. AN INVESTIGATION IS CURRENTLY UNDERWAY, UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    ON (B)(6) 2010, COVIDIEN WAS INFORMED OF A CUSTOMER WHO HAD AN ISSUE WITH A HEPARIN PREFILLED SYRINGE. AS REPORTED TO COVIDIEN BY ANOTHER MFR, THE ATTORNEY ALLEGES THAT THE PT DEVELOPED A FEVER, CHILLS, NAUSEA, VOMITING, STOMACH PAIN, KIDNEY PAIN, WEAKNESS, DIZZINESS, SHORTNESS OF BREATH, AND MUSCLE ACHES AFTER ADMINISTRATION OF THE MONOJECT PREFILL TM 100U/ML HEPARIN LOCK FLUSH SYRINGE 3 ML, REFERENCE NUMBER (B)(4), WHICH HAD BEEN ADMINISTERED TO THE PT ON VARIOUS OCCASIONS FROM 2007 TO 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 30327 12CC 100 UNIT HEP SYR {CAN} 2.5CC HEPARIN PRE-FILL SYRINGE NZW COVIDIEN 8881590123 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR